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Medical Device

Medical Device: Wesper Lab (Single Arm) for Sleep Apnea

N/A

Waitlist Available

Led By German P Digoy, M.D.

Research Sponsored by Tatch Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If 18 years or older, be able to willingly sign a written informed consent form prior to the initiation of any study procedure. If younger than 18 years of age, have a parent or legal guardian voluntarily willing to sign a written informed consent form prior to the initiation of any study procedures. Adult patients unable to provide written informed consent on their own behalf will not be eligible for the study

Be 2 to 21 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 hours

Awards & highlights

Study Summary

This trial is evaluating the effectiveness of a wireless home sleep test called Wesper Lab in diagnosing sleep apnea in children. The study aims to compare Wesper Lab with the standard overnight sleep test called

Who is the study for?

This trial is for children and young adults aged 2 to 21 who are already scheduled for a standard sleep study (PSG) to check for sleep apnea. Participants will use the Wesper Lab home test at the same time as their regular PSG.Check my eligibility

What is being tested?

The study tests how well the Wesper Lab, a wireless home sleep test device, measures sleep apnea compared to traditional overnight polysomnography. It checks if both methods agree on the severity of sleep apnea in participants.See study design

What are the potential side effects?

Since this trial involves non-invasive monitoring with Wesper Lab and an FDA approved pulse oximeter during a routine PSG, side effects are minimal but may include discomfort from wearing sensors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can sign the consent form myself, or if under 18, my guardian can.

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I am between 2 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Agreement of Wesper Lab with Polysomnography (PSG) for the scoring of the apnea/hypopnea index (AHI).

Secondary outcome measures

Agreement of Wesper Lab with Polysomnography (PSG) for the calculation of sleep apnea severity.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Medical Device: Wesper Lab (Single Arm)Experimental Treatment1 Intervention

Participants already undergoing a prescribed polysomnography (PSG) sleep study for the diagnosis of sleep apnea will be asked to simultaneously wear Wesper Lab, a home sleep test device.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tatch Inc.Lead Sponsor

German P Digoy, M.D.Principal InvestigatorAssociate Professor of Otolaryngology, Oklahoma State University Center for Health Sciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria required to participate in this medical study?

"Individuals who are between the ages of 2 and 21 and have been diagnosed with sleep apnea may be eligible to participate in this study. The trial aims to enroll a total of 150 participants."

Answered by AI

Are individuals above the age of 20 eligible to participate in this recruitment for the clinical trial?

"As per the eligibility requirements for this medical research, potential participants must be between the ages of 2 and 21."

Answered by AI

Are there any ongoing efforts to enlist participants for this trial?

"According to the current information on clinicaltrials.gov, this particular trial is no longer actively seeking participants. The initial posting of the study was on March 1st, 2024 and it was last updated on January 11th, 2024. However, there are currently a total of 1644 other trials available that are accepting participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations

2024. "Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218186.

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